Clinical TrialOpioid Use Disorder (OUD)KetaminePlaceboTerminated

Ketamine for OUD and Suicidal Ideation in the ED

This pilot, double-blind, placebo-controlled randomised clinical trial (n=50) led by Brigham and Women's Hospital assesses safety and preliminary efficacy of IV ketamine (0.8 mg/kg over 40 minutes) for individuals with opioid use disorder and suicidal ideation in the emergency department.

Target Enrollment
50 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, placebo-controlled parallel-group trial of a single IV infusion of ketamine 0.8 mg/kg (over 40 minutes) versus matched saline in adults with moderate–severe opioid use disorder presenting to the ED with suicidal ideation.

Primary aim: safety of ketamine treatment in the ED; secondary aims: preliminary efficacy on opioid- and suicide-related outcomes. Safety assessments occur during and after infusion and at follow-up after discharge or inpatient psychiatric treatment.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single IV ketamine infusion for participants with OUD and suicidal ideation (n=25).

Interventions

  • Ketamine0.8 mg/kg
    via IV• single dose• 1 doses total

    Infusion over 40 minutes.

Saline placebo

inactive

Matched-volume 0.9% saline infusion (n=25).

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Matched volume saline over 40 minutes.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • To be eligible, individuals must be/have:
  • English speaking adults aged 18 and above
  • Diagnosed with DSM-5 opioid use disorder, moderate or severe, or clinically suspected opioid use disorder
  • Endorsing suicidal ideation sufficiently severe to meet criteria for referral to an inpatient psychiatric facility or a crisis stabilization unit
  • Any prior history of an opioid overdose
  • Medically cleared

Exclusion Criteria

  • Individuals with any of the following will be excluded:
  • Any psychotic disorder or active homicidality
  • Inability to perform consent due to impaired mental status
  • Current substance intoxication or current (or within the past 1-month) mania, hypomania, mixed-episode, or psychosis
  • Systolic blood pressure persistently elevated above 160 mmHg, diastolic blood pressure greater than 100 mmHg, or heart rate >100 bpm in the ED
  • Clinical Opioid Withdrawal Scale (COWS) score of 12 or greater
  • History of hypersensitivity to ketamine, or experience of emergence reaction
  • History of hypersensitivity to ondansetron or concurrent use of apomorphine
  • History of any illicit or recreational use of ketamine in the past 12 months
  • Receipt of ketamine treatment for depression in the past 3 months
  • History of DSM-5 hallucinogen use disorder, intracranial mass or bleed, porphyria, thyrotoxicosis, seizure disorder other than from alcohol withdrawal, liver cirrhosis, or sleep apnea
  • Cardiac or EKG abnormalities based on history, physical examination or the baseline EKG
  • History within 6 months of thoracic surgery, lung cancer, head trauma, stroke, or myocardial infarction
  • Liver dysfunction with LFTs >3x upper normal limit
  • Current use of medications with known drug–drug interactions with ketamine (e.g., St John's Wort, theophylline, opioid analgesics other than buprenorphine and methadone for the treatment of OUD, CNS depressants other than benzodiazepines or phenobarbital)
  • Pregnant
  • Patients who are breastfeeding
  • ASA class 3 or greater or documented history of difficult airway in the ED
  • Active exacerbation of COPD or asthma
  • Currently participating in or anticipated to participate in a concurrent investigational clinical trial
  • High risk for adverse emotional or behavioural reaction based on the opinion of the study investigators, including evidence of a personality disorder

Study Details

  • Status
    Terminated
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment50 participants
  • Timeline
    Start: 2024-03-01
    End: 2025-05-31
  • Compounds
    KetaminePlacebo
  • Topic
    Opioid Use Disorder (OUD)

Locations

Brigham and Women's Hospital — Boston, Massachusetts, United States

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